Kornimate/medical-research-clean huggingface dataset:
evaluation of the immunogenicity and safety bbibp-corv vaccine for covid-19 in adults in guinea

Conditions: COVID-19; Vaccine Adverse Reaction; Sars-CoV-2 Infection; Healthy Volunteer

Summary: phase ii, non-randomized, open-label, comparative, single center national trial in guinea, aimed to assess the humoral vaccine immune response induced by bbibp-corv vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete covid-19 vaccination schedule.

the main objective of this phase ii trial is to evaluate the humoral immune response induced by the bbibp-corv vaccine in adults one month after complete vaccination regimen against sars-cov-2, comparing younger (up to 45 years old) and elderly (55+ years old) populations. 200 participants will be included. the age categories are 18 - 45 years, 55 - 64 years and 65+ years. the number of participants per age group will be distributed as follows 1:1:0,5. there will be no comparison between population on different vaccines. participants will receive two doses of bbibp-corv at 28 days interval. vaccines will be administered intramuscular (0.5ml per injection) humoral vaccine immune responses, induced by bbibp-corv will be measured by elisa at d0, m1, m2, m6, m12 and m24.

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years old or 55 years and older * be eligible to receive one of the study vaccines as part of the trial * understand and agree to comply with study procedures (visits, telephone calls) * agree not to participate in any other vaccine study during the time of the study * give written informed consent prior to any examination performed as part of the trial exclusion criteria: * age between 46 and 54 years old * positive sars-cov-2 antigenic test * positive sars-cov-2 pcr results less than 48 hours old * history of infection by covid-19 confirmed within 3 months prior to inclusion * symptoms compatible with covid-19: sick or febrile participants (body temperature ≥ 38.0°c) * pregnant or breastfeeding woman * known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) infection) * anti-coagulant treatment * immunosuppressive treatment * contraindication to the proposed vaccine (according to rcp) * patient having received immunoglobulin or another blood product within 3 months prior to inclusion * previously received at least one injection of a sars-cov-2 vaccine * a history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the sars-cov-2 vaccine) * any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Keywords: bbibp-corv elderly sars cov 2 infected participants safety and immunogenicity
effect of a hyperproteic hyperenergetic enteral formula on body composition and vegf in aml during hospital stay

Conditions: Acute Myeloid Leukemia, Adult

Summary: a randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .

patients with acute myeloid leukemia have a high risk of suffering sarcopenia, which decreases the oncology therapy clinical response, functional ability and quality of life. chemotherapy is used in these patients, some of them inhibit angiogenesis and act in an important way in physiological processes of muscle anabolism. the vascular endothelial growth factor (vegf) and its receptors (vegfr) play a crucial role in both normal and malignant angiogenesis. activation of the vegf pathway leads to endothelial cell activation, proliferation and survival. the objective of this study is to compare the effect of the use of a high protein, high energy enteral with omega 3 formula (supportan dkn) against a standard enteral formula (fresubin® original drink) on body composition, days of hospital stay, quality of life, associated muscular strength with levels of vegf in patients with acute myeloid leukemia during induction chemotherapy. an open clinical trial was designed, in which a group of patients will receive, as part of their nutritional requirements a hyperproteic hyperenergetic enteral formula versus standard formula during the 21 days of the first cycle of antineoplastic treatment. we will measure body composition, muscle strength and serum concentrations of vegfr in both groups to be able to compare its effect.

Eligibility criteria:
inclusion criteria: * adult patients with a confirmed diagnosis of aml * tolerance to oral feeding * induction chemotherapy * patients with nutritional risk of positive malnutrition (score +3 nrs). * candidates to receive enteral nutrition, as well as chemotherapy according to medical indications. * life expectancy greater than a week and with the possibility of starting oncological treatment. have informed consent obtained by the patient prior to randomization exclusion criteria: * geriatric patients (\> 60 years) * patients with acute gastrointestinal bleeding, ileus and shock * history of recurrence of neoplasm * renal failure * atrophy of the gastrointestinal mucosa * central nervous system disease, * impaired cardiac function. elimination criteria: lack of follow up incomplete data. insufficient amount of genetic material to perform the determination of the vegf material. absence of the determination of the levels of vegf prior to the start of oncological therapy.

Keywords: nutrition acute myeloid leukemia body composition chemotherapy recovery vegf
outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation with or without proven left atrial posterior wall isolation

Conditions: Atrial Fibrillation

Summary: objective: this prospective study aims to examine the outcome of atrial fibrillation (af) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. the study will be conducted in patients with different types of af: paroxysmal af (paf) and non-paf (persistent af and long standing persistent af). hypothesis: in addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-paf patients.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years 2. af patient undergoing primary catheter ablation (first procedure) 3. ability to give informed consent exclusion criteria: 1. previous ablation of af 2. bleeding disorder 3. reversible causes of af, such as hyperthyroidism and phaeochromocytoma

Keywords: atrial fibrillation ablation
patient reported outcomes registry in patient with cancer cachexia

Conditions: Metastatic Pancreatic Cancer; NSCLC, Metastatic

Summary: evaluation of patient reported outcomes (pro) with tumor cachexia in a real life setting.

the pro xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia. patient reported outcomes (pro) are assessed in a real life setting by a questionnaire consisting of 20 questions: qol is measured by sf12, fatigue by facit-f and cachexia by faact questionnaires, respectively. these data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general qol, fatigue and cachexia and the evaluation of malnutrition.

Eligibility criteria:
inclusion criteria: * documented diagnosis of nsclc uicc stage iiib/iv or pancreatic cancer uicc stage iii/iv * start of the first line palliative systemic treatment * ability to read and understand german * written informed consent exclusion criteria: * none

Keywords: patient reported outcome (pro)
evaluation of antibacterial soap for treatment of lymphedema in a filariasis-endemic area

Conditions: Lymphedema; Cellulitis

Summary: introduction. lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. in these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being. methods. to determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the ste. croix hospital lymphedema treatment clinic in leogane, haiti randomly assigned to receive either antibacterial (safeguard) or placebo (camay) soap and acute attacks monitored monthly for 12 months. both groups received specific instructions on washing and skin care.


Eligibility criteria:
inclusion criteria: patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene). - exclusion criteria: don't meet inclusion criteria. -
physiotherapist-guided home exercise in moderate to severe ms

Conditions: Multiple Sclerosis

Summary: physical activity is a crucial component to wellness and is associated with multiple health benefits. persons with ms may find it challenging to participate in regular physical activity or exercise, which is activity done to improve health and/or fitness. this research will test an innovative web-based intervention to help persons with moderate-to-severe disability manage their condition through a maintenance exercise program with specialized physiotherapist guidance and support. the researchers will examine adherence to the web-based physiotherapy program compared to standard physiotherapy care. forty-five people with ms will be randomly assigned to the web group or standard care group at a rate of 2:1. participants in the web group will receive supported and individualized web-based physiotherapy. participants in the standard care group will receive a written exercise program. regular participation (adherence) in the exercise programs will be evaluated in both groups over six months. the research will also examine participant satisfaction with the programs, safety, ms symptoms, and physical function. a web-based approach may be widely accessible to persons with ms in their own homes and could support long-term participation in physical activity important to wellness.


Eligibility criteria:
inclusion criteria: * diagnosed with ms * moderate to severe disability (pdds 2-7) * able to access the internet in your current living environment exclusion criteria: * already doing structured exercise more than once per week * residing \>300km from saskatoon (unless able to travel to saskatoon for the appointments) * unable to understand the intent and process of this study
predictive value of maternal serum pentraxin 3 (ptx 3) and heparin-binding protein (hbp) for chorioamnionitis in preterm premature rupture of membranes

Conditions: Preterm Premature Rupture of Membrane

Summary: objective: the aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (ptx3) and heparin-binding protein (hbp) for chorioamnionitis in preterm premature rupture of membranes (pprom). method: this observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. there were 60 cases of term premature rupture of membranes (tprom), 60 cases of preterm premature rupture of membranes（pprom）and 60 cases of healthy women. the concentrations of ptx3 and hbp were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (elisa). western immunoblotting was used to analyze the expression of ptx3 and hbp in placental tissue. the localization and immunoreaction of ptx3 and hbp in placenta were determined via immunohistochemistry (ihc).


Eligibility criteria:
inclusion criteria: 1. the pregnant woman is born at a gestational age of 24-40 weeks; 2. the pregnant woman has a single child; 3. regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (prom). exclusion criteria: 1. pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension; 2. insufficiency of vital organ function or complicated tumor; 3. pregnant women with other pregnancy complications besides prom, such as preeclampsia, etc.; 4. neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum) 5. neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.

Keywords: pentraxin 3 heparin-binding protein chorioamnionitis preterm premature rupture of membranes term premature rupture of membranes
study evaluating safety, tolerability, pharmacokinetics and 5 ht1a receptor occupancy

Conditions: Alzheimer's Disease

Summary: the study will include a preliminary pharmacokinetics (pk) / safety / tolerability evaluation in healthy elderly subjects followed by the receptor occupancy (ro) evaluations in healthy elderly subjects and in alzheimer's disease (ad) subjects.


Eligibility criteria:
inclusion criteria: * men or women from 60 years of age at screening. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ecg). exclusion criteria: * history of drug abuse within 1 year before study day 1.
evaluation of the added value of an internet-based educational program for patients with atrial fibrillation.

Conditions: Atrial Fibrillation; Quality of Life; Signs and Symptoms; Health Economy

Summary: this study is prospective, open and randomized concerning the value of an internet-based educational program for patients with atrial fibrillation compared to "care as usual".

in the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. the investigators developed an internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy. the aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.

Eligibility criteria:
inclusion criteria: patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation. exclusion criteria: age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. insufficient knowledge of the swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.

Keywords: atrial fibrillation symptom burden health-related quality of life health economy
home-based disease management program to improve clinical outcomes in patients with heart failure

Conditions: Heart Failure

Summary: although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (qol), and medical cost in patients with heart failure (hf), no study has focused on psychological status as an outcome of disease management in patients with hf. disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with hf. in addition, very little information is available on the effectiveness of disease management programs in areas other than the us and europe.the japanese heart failure outpatients disease management and cardiac evaluation (j-homecare) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, hf hospitalization, and qol in japanese hf patients.


Eligibility criteria:
inclusion criteria 1. age ≥ 18 years exclusion criteria 1. end-stage hf defined as requiring mechanical support or continues intravenous inotropic support 2. a serious life-threatening illness with a life-expectancy of \<6 months within the past 3 months 3. cognitive dysfunction 4. substance abuse or psychotic disorder 5. managed by visiting nursing 6. long distance between patients' home and hospital

Keywords: heart failure disease management
a study to assess sebaceous gland changes and constituents of sebum (skin oil) induced by clascoterone 1% cream in acne patients

Conditions: Acne Vulgaris

Summary: to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment


Eligibility criteria:
inclusion criteria: 1. female or male subjects age 18-35 years. 2. subjects of all fitzpatrick skin types. 3. subjects with moderate facial acne and prominent pores indicating sebaceous gland activity. 4. subjects with oily facial skin. 5. subjects who agree to use only the study product and nothing else to the face. 6. subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face. 7. subjects agree not to introduce any new skin care products during the study. 8. no known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. subjects have signed an informed consent form in compliance with 21cfr part 50: "protection of human subjects." 10. subjects are dependable and able to follow directions and willing to comply with the schedule of visits. 11. subjects in generally good physical and mental health. exclusion criteria: 1. any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics. 2. subjects who are not willing to use the assigned study product to their face as instructed. 3. subjects who have used any topical prescription products on the face for 4 weeks prior to study entry. 4. subjects who have used any otc products on the face for 2 weeks. 5. subjects with clinically significant unstable medical disorders. 6. subjects who are unwilling or unable to comply with the requirements of the protocol. 7. subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 8. subjects currently participating in any other clinical trial.
effects of tdcs for enhancing cognitive function in individuals with persistent post-concussion syndrome

Conditions: Transcranial Direct Current Stimulation; Post-Concussion Syndrome; Functional Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy

Summary: globally, 10 million new traumatic brain injury (tbi) cases are estimated annually, with mild traumatic brain injury (mtbi) accounting for 75-90% of all tbi cases. it is estimated that 40-80% of individuals with mtbi may experience the post-concussion syndrome (pcs), which is characterized by a range of physical, cognitive, and emotional symptoms. although the underlying basis of cognitive dysfunction of patients with persistent pcs remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mtbi. recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (e/i) balance after tbi. yet, there is no consensus for treating chronic symptoms of concussion, and pcs remains a chronic and highly disabling condition. one potential treatment option is transcranial direct current stimulation (tdcs), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. however, research on the therapeutic effect of tdcs on pcs symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. the proposed study aims to address these knowledge gaps by examining the effects of tdcs on the central nervous system function in patients with pcs, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. the study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of pcs after mtbi.


Eligibility criteria:
inclusion criteria: * being 18 years old or older; * having a history of a mild tbi (less than 30 minutes loss of consciousness) 1-6 years prior to the study; * able to communicate in chinese. exclusion criteria: * being without a confirmed diagnosis from the medical practitioner; * having a history of other neurological and psychiatric disorders, skull defect, recent medical instability (within 3 weeks); * being pregnant; * being medication for a psychiatric condition (e.g., major depression, anxiety, schizophrenia); * with any implanted devices or suffering from real claustrophobia or feel uncomfortable in small, enclosed spaces, like mri tunnel